Liver Transplantation
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj. administered for consecutive 3 days in adult subjects to prevent biliary complications after ABO incompatible adult to adult living donor liver transplantation (LDLT). The primary objective of this study is to determine the incidence rate of biliary complications for 48 weeks after liver transplantation. Incidence rate of transplant rejection, DSA, antibody reaction, CMV infection, infectious complications, DIHBS and recurrence rate of HCC as well as adverse events are assessed as additional efficacy and safety endpoints in this study.
Interventions
BIOLOGICALLIV-GAMMA SN Inj.
LIV-GAMMA SN Inj. is administered at a dose of 0.6 g/kg/day from anhepatic phase to Day 2 post-operative to patients undergoing ABO-incompatible liver transplantation as an experimental group.
OTHERNo intervention
None of investigational drugs are administered to patients.
Sponsors
SK Plasma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Completed informed consent process * Male or female aged ≥19 years and \<75 years * Patients scheduled hospitalization for liver transplantation
Exclusion criteria
* Patients who are scheduled or have history of re-transplantation or multiorgan transplantation * Patients receiving living donor in emergency * Patients with Donor Specific Antibody (DSA) ≥ MFI 10,000 or Human Leukocyte Antigen (HLA) crossmatch (+) cytotoxic T-cell ≥ 1:32 * Patients with a history of biliary tract disease * Patients who plasma exchange is forbidden (with a history of allergic or anaphylactic reaction to FFP, albumin, heparin, etc.) * Patients with a history of specific medical conditions * Severe renal failure (eGFR \< 30 mL/min/1.73 m\^2 at screening) * Deep Vein Thrombosis (DVT) or thrombotic complications from Intravenous Immunoglobulin (IVIg) therapy * Cerebrovascular or cardiovascular disease (Hyperviscosity syndrome, Transient Ischemic Attack (TIA), Stroke, Thromboembolism, Unstable angina, etc.) * Clinical state causing secondary immunodeficiency (Leukemia, Lymphoma, Multiple myeloma, HIV infection, Chronic or Cyclic neutropenia (Absolute neutrophil \< 500/mm\^3), etc.) * Uncontrolled hypertension (Systolic blood pressure \> 160 mmHg or Diastolic blood pressure \> 100 mmHg) * Hemolytic or hemorrhagic anemia * Decreased cardiac functions * Bacterial, fungal or viral infection making liver transplantation forbidden * Intraductal or vascular infiltration observed in patients with hepatocellular carcinoma using medical imaging before liver transplantation * Patients metastasized to organs except for liver or diagnosed cancer except for liver cancer and squamous cell carcinoma within 5 years from screening * Patients with sepsis * Patients who had interventional therapy in blood vessels (hepatic vein, portal vein, hepatic artery, etc.) or bile ducts before LDLT * Patients who have allergy or hypersensitivity to blood products, blood-derived products, IVIg or immunoglobulin G (IgG) products * Patients who have immunoglobulin A (IgA) deficiency or anti-IgA antibody * Patients who are pregnant and nursing * Patients unwilling to use adequate method of contraception (hormonal methods, intrauterine device or intrauterine system, vasectomy, tubal ligation, etc.) during this study * Patients who had received other investigational products within 8 weeks from complete consent or who are scheduled to receive other investigational products during this study * Others whom the investigator considers ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of biliary complications | 48 weeks | The number and rate of subjects with biliary complications including cholangitis, biliary leaks or biliary strictures for 48 weeks after liver transplantation (Experimental group vs. Comparator group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Donor Specific Antibody (DSA) | 48 weeks | The number and rate of subjects with Donor Specific Antibody (DSA) for 48 weeks after liver transplantation |
| Rate of antibody reaction by ABO subtype | 48 weeks | The number and rate of subjects with antibody reaction by ABO subtype analysis for 48 weeks after liver transplantation |
| Rate of Cytomegalovirus (CMV) infection | 48 weeks | The number and rate of subjects with Cytomegalovirus (CMV) infection for 48 weeks after liver transplantation |
| Rate of transplant rejection | 48 weeks | The number and rate of subjects with transplant rejection for 48 weeks after liver transplantation |
| Rate of Diffuse Intrahepatic Biliary Stricture (DIHBS) | 48 weeks | The number and rate of subjects with Diffuse Intrahepatic Biliary Stricture (DIHBS) for 48 weeks after liver transplantation |
| Recurrence rate of Hepatocellular Carcinoma (HCC) | 48 weeks | The recurrence rate of subjects with Hepatocellular Carcinoma (HCC) for 48 weeks after liver transplantation |
| Rate of infectious complications | 48 weeks | The number and rate of subjects with infectious complications for 48 weeks after liver transplantation |
Countries
South Korea
Outcome results
None listed